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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
53 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
The data are taken from 2 fully reliable studies with acrylic acid - the corresponding organic acid of Magnesium acrylate. In contrast to the free acid Magnesium acrylate has nearly no irritating properties. As the effect levels of acrylic acid are mainly determined by its irritating properties a read across to Magnsium acrylate will overestimate the toxicity. That means the effect levels of Magnesium acrylate should be considerably higher. Therefore the results of the studies with acrylic acid can be taken as a worst case to evaluate Magnesium acrylate. In summary the studies are sufficient for the evaluation of the fertility after oral administration
Additional information
Short description of key information:
In 2 oral reproduction toxicity studies, a one-generation and a two-generation reproduction toxicity study with administration of Acrylic acind in the drinking water no effects on reproductive function (fertility) were observed. Some signs of postnatal developmental toxicity (retarded body weight gain of the pups) were seen following exposure of the parental generation, however at dose levels that led to reduced food intake and weight gain in the dams. No gross abnormalities were observed in the offspring. A NOEL/fertility of 460 mg/kg bw/d was derived from the guideline 2-generation study in rats according to European Union Risk Assessment Report Acrylic Acid, Volume 28ISBN 92-894-1272-0:
NOEL for reproductive function in rats was 460 mg/kg bw/d (administration in the drinking water).
NOEL for general toxicity was 240 mg/kg bw/d (administration in the drinking water).
NOEL for the F1 generation was 53 mg/kg bw/d (administration in the drinking water).

Justification for selection of Effect on fertility via oral route:
2 key studies: a one-generation and a two-generation study with rats using oral administration via drinking water

Effects on developmental toxicity

Description of key information
Developmental studies with the oral route of administration are not availiable. However, in 2 reproductive toxicity studies in rats with administration of Acrylic acid in the drinking water the postnatal developmental toxicity was investigated. Retarded body weight gain of the pups was seen following exposure of the parental generation, however at dose levels that led to reduced food intake and weight gain in the dams. No gross abnormalities were observed in the offspring.
From these data a NOEL for the offspring of rats of 53 mg/kg bw/d can be derived.
In 2 studies with inhalative exposure of pregnant rats and rabbits no prenatal developmental toxicity was observed, even at concentration levels that produced some signs of maternal toxicity. No specific teratogenic potential could be revealed for dose levels up to and including 360 ppm = 1060 mg/kg bw/d (rats), resp. 225 ppm = 663 mg/kg bw/d (rabbits):
NOEL for maternal toxicity of rabbits was 25 ppm (74 mg/m³).
NOEL (rats) was 360 ppm = 1060 mg/kg bw/d.
NOEL (rabbits) was 225 ppm = 663 mg/m³ (Cited from European Union Risk Assessment Report Acrylic Acid, Volume 28ISBN 92-894-1272-0 (EU, 2002))
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
53 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Cited from European Union Risk Assessment Report Acrylic Acid, Volume 28ISBN 92-894-1272-0
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEC
663 mg/m³
Study duration:
subacute
Species:
rabbit
Quality of whole database:
The data were taken from 2 fully reliable studies with acrylic acid - the corresponding organic acid of Magnesium acrylate. In contrast to the free acid Magneium acrylate has nearly no irritating properties. As the effect levels of acrylic acid are mainly determined by its irritating properties a data waiving to Magnsium acrylate will overestimate the toxicity. That means the effect levels of Magnesium acrylate should be considerably higher. Therefore the results of the studies with acrylic acid can be taken as a worst case to evaluate Magnesium acrylate. In summary the study is sufficient for the evaluation of the developmetal toxicity after inhalative exposure.
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
Developmental studies with the oral route of administration are not availiable. However, in the 2 reproductive toxicity studies in rats (administration in drinking water) the postnatal developmental toxicity was investigated.

Justification for selection of Effect on developmental toxicity: via inhalation route:
2 key studies, one with rats and another one with rabbits

Justification for classification or non-classification

According to the present database for toxicity for reproduction there are no reasons to classify Acrylic acid as a reproductive toxicant

according to the criteria of regulation (EC) 1272/2008 and EEC Directive 67/548.

This is in line with the European Union Risk Assessment Report Acrylic Acid, Volume 28ISBN 92-894-1272-0 (EU, 2002): " ...

In oral reproductive toxicity studies (rats) no effects on reproductive function (fertility) were observed. ... No prenatal developmental toxicity was observed (rats and rabbits, inhalation), even at concentration levels that produced some signs of maternal toxicity. ... A NOAEL/developmental toxicity of 225 ppm (according to 663 mg/m³) was derived from the developmental toxicity study in rabbits ... According to the present database for toxicity for reproduction there are no reasons to classify acrylic acid as a reproductive toxicant...."

The same holds true for Magnesium acrylate.

Additional information